Overview

Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
All
Summary
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Florida Eye Microsurgical Institute
Collaborator:
Bausch & Lomb Incorporated
Treatments:
Bromfenac
Cyclosporine
Cyclosporins
Ketorolac
Ketorolac Tromethamine
Criteria
Inclusion Criteria:

- Must be in general good health

- Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

- Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy

- Patients who are pregnant or nursing females

- Unwilling to discontinue use of contact lenses during the run-in and duration of the
study

- Presence or history of any systemic or ocular disorder or condition that could
possibly interfere with the interpretation of the study results in the study eye

- Previous treatment failure on CSA 0.05% (Restasis)

- Known hypersensitivity to any component of the study or procedural medications

- Participation in any other clinical trial within 30 days prior to screening

- Known contraindication to any study medication or any of their components.

- Should not be taking any oral anti-histamines, beta blockers or diuretics.